Monday, October 31, 2011

How long is a financial conflict of interest still a conflict? And for how long after a conflict "ceases to exist" should a researcher continue to disclose that conflict? These intriguing questions are raised in today's Rest of the Story.

Last week, I discussed how a researcher who has made substantial contributions to the field of treatment of patients for smoking cessation - Dr. Michael Fiore - had a significant conflict of interest with Big Pharma by virtue of his position as a chair endowed by GlaxoSmithKline, which he acknowledged gave him "access to up to $50,000 per year to support [his] University approved and sanctioned educational, research, and policy activities."

This chair position was apparently held by Dr. Fiore from 1997 until February 2010, when he resigned the position.

It appears that in at least some of his current publications, Dr. Fiore has stopped disclosing this conflict of interest to readers.

In a recent set of two articles on treatment for smoking cessation published in the Annals of Behavioral Medicine in April 2011 (article 1; article 2), the conflict of interest statement regarding Dr. Fiore states only that: "Over the last 3 years, Michael C. Fiore served as an investigator on research studies at the University of Wisconsin that were funded by Nabi Biopharmaceuticals." These articles give no indication that as of the start of 2010, and for the previous 13 years, Dr. Fiore held a chair position endowed by GlaxoSmithKline.

In August 2011, an erratum to the latter article was published. This would have been an opportunity to correct the disclosure statement had the omission of mention of the Big Pharma endowed chair position had merely been an oversight.

In a December 2010 article on treatment for smoking cessation published in the Wisconsin Medical Journal, the conflict of interest statement regarding Dr. Fiore states only that: "Over the last 3 years, Dr Fiore has served as an investigator in research studies at the University of Wisconsin that were funded by Pfizer and Nabi Biopharmaceuticals." Again, the article gives no indication that as of the start of 2010, and for the previous 13 years, Dr. Fiore held a chair position endowed by GlaxoSmithKline.

The Rest of the Story

In my opinion, a conflict of interest does not disappear overnight. In the present case, I believe that the existence of a 13 year period during which the researcher held a Big Pharma endowed chair position is absolutely relevant today, even though the researcher has resigned that position. I believe that readers deserve to be informed about that 13-year financial relationship between the researcher and the pharmaceutical industry and that this relationship is relevant to the evaluation of potential bias in the conduct and reporting of the research, even though the relationship ceased to exist in early 2010. Thus, I believe that the conflict should continue to be reported and that the investigator has an obligation to inform journal readers of the past financial relationship.

Imagine if a scientist at Philip Morris resigned his position to take a job at an academic institution. Now imagine that scientist published a tobacco-related paper in a scientific journal but failed to disclose his past employment by Philip Morris. I can guarantee that we in the tobacco control community would be attacking that scientist for failing to disclose his prior employment at Philip Morris.

Clearly, a significant conflict of interest does not simply disappear overnight. And I would argue that the forthrightness which we would expect from tobacco industry researchers is the same that we should expect from tobacco control researchers. Past conflicts of interest should be disclosed if they are significant and relevant. Certainly, a 13-year financial relationship with a pharmaceutical company, in which a researcher holds a chair position endowed by that company and has access to tens of thousands of dollars to support his work constitutes a significant and relevant financial conflict of interest.

Tuesday, October 25, 2011

In his disclosure statement in a recent article in the New England Journal of Medicine about the treatment of smokers in the health care setting, Dr. Michael Fiore - chair of a panel that advised the Joint Commission on standards for hospital treatment of smoking - discloses the existence of his previous endowed chair position (which he recently resigned) which was funded by GlaxoSmithKline.

In the disclosure, Dr. Fiore emphasizes that no money from GlaxoSmithKline's gift was ever paid directly to him. He discloses as follows: "In 1997, the University of Wisconsin (UW) appointed me to a named Chair for the study of Nicotine Dependence made possible by a gift from GlaxoWellcome. No funds from that Chair have ever been paid directly to me and no funds from that Chair were used to pay my UW salary over the last 10 years."

The Rest of the Story

Unfortunately, this disclosure is quite misleading and if you ask me, a bit sneaky. Dr. Fiore emphasizes that he never personally received money from the endowment and that no funds from the pharmaceutical company were used to pay his salary. However, he fails to explain that under the terms of the endowed chair position, he had "access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities."

Thus, although he may not have received funds to himself directly, he admits in sworn testimony that he had access to up to $50,000 a year of GlaxoSmithKline money to support his work, but fails to disclose as much in the "disclosure." It does not appear that he adhered to the form's directions: "err on the side of full disclosure."

Why would one hide from readers the fact that one had access to such a huge amount of pharmaceutical company money each year to support one's work. If one is going to mention this endowed chair position, it seems important to disclose that. In fact, as Dr. Fiore told the Court in the DOJ tobacco lawsuit, that is exactly the way the endowed chairmanships work: the very idea is apparently that the interest on the endowment is accessible to the professor to support his work.

Why is this important? Because it creates the appearance that Dr. Fiore has something to hide. Why the need to deceive readers about the extent of his financial relationship with Big Pharma?

It is problematic enough to have a financially conflicted panel chair writing accreditation standards. But when that individual appears not to be forthright in disclosing the full nature of the potential conflict and appears to be hiding the full nature of his financial relationships with the pharmaceutical industry, I believe it is not only problematic, but antithetical to objective science and policy.

Monday, October 24, 2011

Last week, I revealed that the Joint Commission's new tobacco treatment accreditation standard was created by a panel whose chair is financially conflicted by virtue of current and multiple past financial relationships with pharmaceutical companies that market or are developing smoking cessation drugs. As I noted, the standard requires hospitals to offer smoking cessation drugs to every smoking patient upon discharge. I also explained why such a requirement is inappropriate since it violates physician autonomy.

Today, I note that the financial disclosure statement submitted by the panel chair is deceiving, because it reports only the most recent conflicts, hiding from the reader the long history of the chair's financial relationships with multiple pharmaceutical companies.

As I reported:

In 2008, Dr. Fiore reported "that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

According to Dr. Fiore's testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities."

In his 2005 testimony, Dr. Fiore also admits that he did "consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

In 2000, Dr. Fiore reported that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome."

The Rest of the Story

In his disclosure statement in a recent article in the New England Journal of Medicine about the treatment of smokers in the health care setting, Dr. Fiore discloses only his current funding from Nabi Pharmaceuticals, not his prior funding by or consultancies/lectures for Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome.

He discloses the existence of his endowed chair position (which he has resigned), but fails to explain that he had "access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities." Instead, he emphasizes that no funds from that endowment were ever paid "directly to him."

The disclosure is therefore deceiving to readers and does not reveal the full extent of his past financial relationships with pharmaceutical companies that manufacture smoking cessation medications.

Importantly, it is not that Dr. Fiore is being untruthful. The form instructs authors to report financial conflicts within the past 3 years, and Dr. Fiore does just that. The problem is that disclosing current conflicts may not paint an accurate picture of an investigator's potential biases when there is a long history of previous conflicts of interest, as there is in this case. Thus, I believe that investigators should voluntarily disclose significant past conflicts, even if the disclosure form does not require it. Otherwise, readers may not get an accurate picture of the potential biases that may be operating and could have the appearance of influencing the conduct or reporting of the research.

Tuesday, October 18, 2011

Yesterday, I revealed that the Joint Commission's new tobacco treatment accreditation standard was created by a panel whose chair is financially conflicted by virtue of current and multiple past financial relationships with pharmaceutical companies that market or are developing smoking cessation drugs. As I noted, the standard requires hospitals to offer smoking cessation drugs to every smoking patient upon discharge.

The purpose of yesterday's post was not necessarily to criticize the requirement itself, but to criticize the fact that the standard was set by a severely conflicted panel: one whose chair has and has had financial conflicts of interest with Big Pharma.

Today, I explain why this requirement is inappropriate.

The Rest of the Story

Quite simply, the requirement is inappropriate because it requires hospitals to offer smoking cessation medication to every smoking patient, even if in the judgment of the treating physician, prescribing a smoking cessation drug is not the most appropriate and effective treatment for his or her patient.

There are many available treatments for smoking dependence and the most effective treatment plan should be individualized. As with most other aspects of medicine, there is no room for a one-size-fits-all, strictly prescribed treatment plan for every patient, regardless of individual circumstances.

Take the example of type II diabetes. One would not set a standard that requires every patient diagnosed with type II diabetes to be treated with an FDA-approved diabetes medication. In fact, 90% of cases of type II diabetes can be adequately treated with exercise and diet alone. To require every hospital to prescribe a diabetes medication to every type II diabetes patient upon discharge would be inappropriate. The appropriate treatment depends on the individual circumstances.

However, the Joint Commission panel's requirement ignores individual circumstances and undermines the judgment of the treating physician in favor of setting a one-size-fits-all mandate that every smoker be prescribed an FDA-approved smoking cessation drug. In many cases, this will not be the most appropriate choice of treatment. Yet hospitals may risk losing accreditation if they fail to follow the standard.

For example, consider a patient with the following history:

Patient X is admitted and treated for a kidney stone. She has a 25 year history of smoking. She has tried nicotine replacement therapy on six different occasions and failed to quit smoking on any of those occasions. She tried Chantix once but discontinued the drug because of severe side effects. Two years ago, she tried hypnotherapy which was very successful. She kept off cigarettes for nearly two years. However, she resumed smoking one month prior to admission due to the stress related to the loss of her job. She is now employed at a new position which she loves, but she hasn't tried to quit smoking since she resumed working.

In this case, the treating physician might legitimately and appropriately believe that the best treatment for the patient would be to try hypnotherapy again. She tried NRT six times and failed so prescribing NRT does not seem likely to be effective. Prescribing Chantix is probably not appropriate given the severe side effects the patient experienced. However, the patient has already been quite successful with hypnotherapy and her sustained period of cessation was interrupted only because of severe stress, which has now been relieved. It seems that a second trial of hypnotherapy might be the most effective and appropriate approach. At very least, it would be reasonable for a physician to so opine.

The Joint Commission panel's standard, however, would find this physician and this hospital in non-compliance. The patient must be offered an FDA-approved smoking cessation drug. Hypnosis doesn't cut it. Acupuncture doesn't cut it. Electronic cigarettes do not cut it. Even if the patient has previously had success with one of these approaches and no success with FDA-approved cessation drugs.

In many ways, this violates a basic principle of medicine: that each patient should be treated in that patient's best interests, without regard to the financial profits of corporations. In this case, the decision is being made not based on what is best for the patient, but what is best for the pharmaceutical companies.

That such a requirement was developed by a panel whose chair has a history of financial conflicts of interest with Big Pharma makes it completely unacceptable.

Monday, October 17, 2011

The Joint Commission is a body that sets standards for the accreditation of hospitals and health care facilities. Since most states require hospitals to be accredited to receive Medicaid reimbursement, following the standards set by the Joint Commission is quite important for most hospitals.

Recently, a panel of the Joint Commission developed standards regarding tobacco use screening and treatment. These standards go into effect in January 2012 and they therefore become a part of the accreditation assessment for hospitals.

While some aspects of the standards set by the panel are straightforward and non-controversial (e.g., all patients should be screened for tobacco use), one striking aspect of the standards is that every patient should be treated with smoking cessation drugs, unless there is a specific contraindication.

As stated by the panel, the smoking treatment standards are "consistent with the 2008 United States Public Health Service Guideline, Treating Tobacco Use and Dependence" and require "that all tobacco users be identified, that tobacco users be provided or offered both evidence-based counseling and medications during the hospitalization and upon discharge, and that tobacco use status be assessed post-discharge."

According to the panel's standards, not only must every patient be treated with smoking drugs during hospitalization (unless contraindicated), but every patient should be prescribed an FDA-approved smoking cessation drug upon discharge.

This recommendation is not exactly evidence-based, because there is a large body of research showing that FDA-approved smoking cessation drugs are highly ineffective, failing to work in the overwhelming majority of patients who are treated with them. Long-term success rates with these drugs are on the order of about 8%. Thus, they have about a 92% failure rate. This makes the recommendation that every patient be prescribed one of these drugs upon discharge quite curious.

The Rest of the Story

Perhaps the recommendation that every patient be prescribed one of the dismally effective FDA-approved smoking cessation drugs is not so mysterious when one learns that the chair of the Joint Commission panel that set this standard has a conflict of interest by virtue of his receiving grant funding from a pharmaceutical company that is in the late stages of developing what it hopes will soon be ...

... an FDA-approved smoking cessation drug.

Moreover, panel chair has a long history of financial conflicts of interest with pharmaceutical companies that manufacture FDA-approved smoking cessation drugs.

The panel chair is Dr. Michael Fiore, who is currently receiving grant funding from Nabi Pharmaceuticals, which has a smoking cessation drug in the late stages of development. The drug is a nicotine vaccine which has been given fast track status by the FDA "for use as a therapeutic for smoking cessation."

Clearly, it is to Nabi Pharmaceutical's great financial interest to have in place as it begins to market this drug a hospital standard requiring all smokers to be prescribed at discharge and FDA-approved smoking cessation drug.

We are talking about an enormous amount of money here. Nabi Pharmaceuticals estimates that the nicotine vaccine market will be $2.1 billion in sales: "The smoking cessation Rx market is young and growing. Datamonitor estimates that the market will grow at a compound annual growth rate of 11% and will reach approximately $3.8 billion by 2018. Datamonitor forecasts that nicotine vaccines will account for $2.1 billion of these sales."

Thus, NicVAX is projected to be the most prescribed smoking cessation medication and the drug to benefit most from the Joint Commission panel's recommendation that every smoking patient leave the hospital with a smoking cessation drug prescription in hand. In fact, giving patients the nicotine vaccine prior to discharge will become the easiest way for hospitals to meet the Joint Commission panel's standards.

On top of the current financial conflict of interest with Big Pharma, Dr. Fiore has a long history of similar conflicts: In 2008, Dr. Fiore "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."

In 2008, Dr. Fiore reported "that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

According to Dr. Fiore's testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities." Dr. Fiore recently gave up this endowed Chair position, but the past conflict is enormous and it appears that much of the panel's work occurred during a time when this conflict was still present.

In his 2005 testimony, Dr. Fiore also admits that he did "consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

In 2000, Dr. Fiore reported that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome."

I have no problem with researchers receiving pharmaceutical funding to conduct clinical research. However, scientists with financial conflicts of interest should not be put in a position of making national recommendations regarding the use of those medications. And they absolutely should not be in the position of setting standards for hospital accreditation when those standards involve the use of medications made by companies with which they have financial conflicts of interest.

This is not an issue of small potatoes. We're talking about potentially $2.1 billion of sales for Nabi Pharmaceuticals. Having Dr. Fiore as chair of the technical advisory panel for the Joint Commission on smoking cessation treatment standards is like giving Big Pharma a seat at the table. Why not just allow the pharmaceutical companies to write the standards that dictate hospitals' prescribing patterns for smoking cessation drugs? Frankly, such a process would have resulted in precisely the same recommendation as this expert panel.

It's a shame that the Joint Commission allowed financially conflicted scientists to participate in the setting of standards for hospitals. It gives pharmaceutical company interests an undue influence - albeit indirectly - on drug prescription policy.

Wednesday, October 12, 2011

The results of the first clinical trial of electronic cigarettes, reported yesterday in the journal BMC Public Health, suggest that these devices may be more effective than traditional NRT products for smoking cessation and may be particularly effective in smokers who are unmotivated to quit.

The subjects were 40 healthy, adult, regular smokers with no interest in quitting. They were provided with electronic cigarettes and minimal intervention (a baseline and four follow-up clinic visits). They were not instructed to try to quit smoking, but were simply allowed to use the electronic cigarettes however they wished.

The sustained smoking abstinence rate at six-month follow-up was 22.5%.

The proportion of subjects who experienced a sustained reduction in the amount smoked by at least 50% was 32.5%.

Thus, 55% of subjects either cut down their consumption by 50% or more or quit smoking altogether at six months follow-up.

No serious adverse events were reported in the study.

The authors conclude: "Although not formally regulated as a pharmaceutical product, the e-Cigarette can help smokers to remain abstinent or reduce their cigarette consumption. By replacing tobacco cigarettes, the e-cigarette can only save lives. Here we show for the first time that e-Cigarettes can substantially decrease cigarette consumption without causing significant side effects in smokers not intending to quit."

The Rest of the Story

Based on a Cochrane review of seven studies that measured smoking cessation using nicotine replacement therapy (NRT), the average 6-month point prevalence of smoking abstinence is only 17.8%, and the 6-month point prevalence of smoking abstinence in the pooled data from these studies is only 11.9%. However, these were generally studies of smokers who were motivated to quit. The fact that this trial found a 6-month abstinence rate of 22.5% among a sample of smokers who were not motivated to quit is quite encouraging.

Moreover, the NRT clinical trials generally involved substantial intervention and encouragement to quit smoking. This trial simulated a real-life experience, where no motivation or support was offered to subjects to quit smoking. In fact, smokers who expressed interest in cessation services were withdrawn from the study. The fact that 22.5% of smokers quit and an additional 32.5% reduced their cigarette consumption by at least half suggests that electronic cigarettes are a promising strategy for both harm reduction (reduction in cigarette consumption) and smoking cessation.

Further trials are necessary to confirm these results and especially, to try electronic cigarettes as a strategy for smoking cessation among smokers who are motivated to quit. Nevertheless, the results of this initial clinical trial are encouraging. Electronic cigarettes appear to be a promising strategy for smoking cessation. Use of these devices among smokers who are unable to quit with other available methods (such as NRT) should be encouraged by health professionals, anti-smoking groups, and the FDA.

Tuesday, October 11, 2011

And Why is FDA Scaring Ex-Smokers About Use of Electronic Cigarettes But Failing to Remove Propylene Glycol from Regular Cigarettes?

Most electronic cigarettes involve the vaporization of a liquid containing nicotine dissolved in glycerin and/or propylene glycol. The major question regarding the long-term safety of these devices is whether or not long-term inhalation of propylene glycol may have adverse respiratory effects. Two initial studies, one conducted recently by Philip Morris, suggest that propylene glycol appears to be safe for long-term inhalation. Nevertheless, the chief health concern regarding e-cigarettes remains the long-term effects of inhalation of propylene glycol and any other chemicals resulting from the heating of propylene glycol.

Other than that (and the effects of nicotine exposure itself), there are really no outstanding health concerns regarding electronic cigarettes, since the issue of diethylene glycol seems to have been solved and the levels of carcinogens (tobacco-specific nitrosamines) in electronic cigarettes are only trace levels, comparable to those in nicotine patches and nicotine gum.

With this as background, consider that at least eight anti-smoking and health groups have called for the removal of electronic cigarettes from the market, because they do not feel that these products have been deemed safe for use. Presumably, these groups are concerned about the long-term effects of propylene glycol inhalation, and the inhalation of byproducts resulting from the heating of propylene glycol.

Similarly, the FDA has scared ex-smokers about the toxins in electronic cigarettes, encouraging them to return to cigarette smoking rather than remain smoke-free using e-cigarettes, presumably also because of concerns over the effects of the long-term inhalation of propylene glycol and any associated byproducts of the heating of propylene glycol.

The Rest of the Story

If the FDA and the anti-smoking and health groups are so concerned about the effects of long-term inhalation of propylene glycol and any byproducts that result from heating propylene glycol, then these very same groups ought to be immediately banning (or calling for a ban on) the use of propylene glycol in regular cigarettes.

After all, if the concerns about the safety of long-term inhalation of propylene glycol are serious enough that we need to discourage smokers from switching from regular cigarettes to electronic cigarettes, then certainly we must have enough concern about long-term inhalation of propylene glycol to require the elimination of this additive from all cigarettes.

And if we are concerned enough about the potential effects of byproducts that result from the simple heating of propylene glycol, then certainly we must be even more concerned about the health effects of combusted propylene glycol, as occurs in many cigarettes.

Since propylene glycol is an additive, the FDA could easily ban its use in regular cigarettes.

Why aren't the anti-smoking groups calling for a ban on propylene glycol in cigarettes? Why hasn't the FDA taken rule-making action to prohibit the use of propylene glycol in cigarettes?

The answer, I believe, is that the FDA's regulation of tobacco products is a sham. It is essentially a Congressional hoax -- a deal set up between politicians and Philip Morris -- to achieve the dual purposes of providing a political victory to the politicians (making it look like they were standing up to Big Tobacco) and an economic victory to Philip Morris (institutionalization of its dominant market share and the elimination of the most serious potential threats to cigarette regulation that could otherwise substantially put a dent in its profits).

Not only is the entire idea of FDA regulation of tobacco products a sham, but the way in which the agency is implemented the law is as well. The approach so far has been to give the most scrutiny to the safest of the spectrum of products on the market (a.k.a, the initial agency ban on electronic cigarettes, the focus on dissolvable tobacco products) and to let the most hazardous products continue to kill hundreds of thousands of Americans, unfettered by meaningful and significant regulation (a.k.a., no ban on menthol cigarettes, no ban on propylene glycol in cigarettes, no regulation of any other hazardous chemicals in cigarettes, no regulation of carcinogens in cigarettes, etc).

In other words, so far the FDA has done absolutely nothing to reduce cigarette use or to make cigarettes safer. It has, however, undermined successful smoking cessation for thousands of successful ex-smokers by urging them to return to regular cigarettes rather than use electronic cigarettes which are loaded with "toxins," "carcinogens," and "anti-freeze."

The anti-smoking groups, for their part, are playing right along with the scam. On the one hand, they are apparently concerned about the effects of long-term inhalation of propylene glycol, demanding that it be shown to be safe before being allowed to be used to help get smokers off of regular cigarettes. On the other hand, they are unwilling to step up and apply the same principle to the real cigarettes, as not a single one of them has called for the FDA to remove propylene glycol as an additive to regular cigarettes.

To be clear, I am not myself calling for a ban on propylene glycol in cigarettes. In fact, I disapprove of the entire idea of regulating the safety of this product by controlling the levels of individual constituents, when there are between 10,000 and 100,000 of those constituents in tobacco smoke. I think the entire process - the entire regulatory scheme - is absurd.

However, I do expect some consistency from anti-smoking groups and from the FDA. I do expect regulation and policy to be guided by science, rather than by politics and ideology. So far, science is taking a back seat. To be exact, the back row of seats in a long, stretch limousine.

In my view, it is impossible for an objective discussion of smoking cessation treatment (e.g., the effectiveness of pharmaceuticals) and alternative nicotine delivery products (such as electronic cigarettes) to take place at a conference sponsored by pharmaceutical companies.

For example, imagine that the conference were being sponsored by an electronic cigarette company. Arguably, tobacco control advocates from across the country would vigorously protest, demanding that the sponsorship be rescinded because no objective consideration of the role of electronic cigarettes in tobacco control can take place at a conference where money is coming in from the electronic cigarette companies.

Well the same is true with pharmaceutical sponsorship. How can the role of smoking cessation drugs be objectively considered at a conference sponsored by the manufacturers of those very products?

The Rest of the Story

While the 2012 sponsors of the National Conference on Tobacco or Health have not yet been announced, I put the early odd of the conference not accepting Big Pharma sponsorship at 13:1. On its web site page seeking sponsors, the conference is highlighting its past sponsorship by pharmaceutical companies, including Pfizer and GlaxoSmithKline. This seems to indicate a willingness, if not a desire, to obtain pharmaceutical sponsorship again this year for the 2012 conference.

Monday, October 03, 2011

The Boston Public Health Commission is considering a new regulation which would ban the use of electronic cigarettes in the workplace. The regulation would also restrict the sale of electronic cigarettes to minors and require a permit for selling these products.

The proposed regulation cites as a justification for the ban on electronic cigarette use (vaping) in the workplace: "the U.S. Food and Drug Administration has conducted laboratory tests that found e-cigarettes contain toxic chemicals and carcinogens; and the health effects of involuntary exposure to e-cigarette vapors containing these chemicals and carcinogens is unknown."

The Rest of the Story

The FDA scared the public and implied that electronic cigarettes present a substantial risk of cancer to users by reporting its laboratory finding that electronic cigarettes are dangerous because they contain carcinogens. The FDA failed to inform the public about the level of carcinogens they detected and how it compares to the level of tobacco-specific nitrosamines in regular cigarettes and in nicotine replacement products. The truth is that the FDA found only trace levels of carcinogens, comparable to those found in nicotine patches and nicotine gum, and orders of magnitude below the levels of these same carcinogens in regular cigarettes.

The rest of the story is that:

The FDA found only trace levels of tobacco-specific nitrosamines in electronic cigarettes, comparable to those found in FDA-approved nicotine replacement products like nicotine patches and nicotine gum.

The levels of carcinogens that have been detected in electronic cigarettes are orders of magnitude lower than in regular cigarettes, indicating that electronic cigarettes are likely much safer than regular cigarettes in terms of cancer risk.

The minute levels of tobacco-specific nitrosamines in electronic cigarettes are a necessary result of the extraction of nicotine from tobacco. Overall, these devices deliver nicotine with only a few other chemicals, compared to the delivery of nicotine plus tens of thousands of chemicals and more than 60 proven carcinogens in regular cigarettes.

There is no evidence, and little reason to believe, that there would be any significant exposure to carcinogens among bystanders in the proximity of electronic cigarette users.

As far as the presence of "toxic chemicals" goes, the FDA reported only one such chemical (diethylene glycol) and it was present in just one cartridge of one brand of electronic cigarettes. Subsequent to that investigation, multiple brands of electronic cigarettes have been tested for diethylene glycol and not a single brand has been found to contain this chemical. It appears that this was an anomaly caused by one company's use of a non-pharmaceutical grade of propylene glycol. The use of pharmaceutical grade propylene glycol should not result in the presence of diethylene glycol in the electronic cigarette, which appears to be the case with every other brand of electronic cigarettes that has been tested subsequently.

The public needs to understand that there is presently no more scientific justification for banning electronic cigarette use in the workplace than there is for banning the use of the nicotine inhaler, which many smokers are using in an attempt to quit smoking. Both contain similar levels of tobacco-specific nitrosamines, and there is no evidence that the use of these inhaled products results in any significant carcinogenic exposure among bystanders.

Moreover, the statement that we don't know what vapers are inhaling is a myth. Electronic cigarette emissions have been tested in numerous laboratory studies. Cahn and I reviewed these studies in our review article published in the Journal of Public Health Policy.

We concluded as follows:

"As ~5300 of the estimated 10 000–100 000 chemicals in cigarette smoke have ever been identified,[4] we already have more comprehensive knowledge of the chemical constituents of electronic cigarettes than tobacco ones. We were able to identify 16 studies[5–17] that have characterized, quite extensively, the components contained in electronic cigarette liquid and vapor using gas chromatography mass spectrometry (GC-MS) (Table 1). These studies demonstrate that the primary components of electronic cigarette cartridges are propylene glycol (PG), glycerin, and nicotine. Of the other chemicals identified, the FDA has focused on potential health hazards associated with two: tobacco-specific nitrosamines (TSNAs) and diethylene glycol (DEG).[5]

TSNAs have been detected in two studies at trace levels.[5,6] The maximum level of total TSNAs reported was 8.2 ng/g.[6] This compares with a similar level of 8.0 ng in a nicotine patch, and it is orders of magnitude lower than TSNA levels in regular cigarettes.[18] Table 2 shows that electronic cigarettes contain only 0.07–0.2 per cent of the TSNAs present in cigarettes, a 500-fold to 1400-fold reduction in concentration. The presence of DEG in one of the 18 cartridges studied by the US Food and Drug Administration (FDA) is worrisome, yet none of the other 15 studies found any DEG. The use of a non-pharmaceutical grade of PG may explain thiscontamination.

Other than TSNAs and DEG, few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns. Although the existing research does not warrant a conclusion that electronic cigarettes are safe in absolute terms and further clinical studies are needed to comprehensively assess the safety of electronic cigarettes, a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products."

In summary then, there is presently no evidence that electronic cigarettes pose any known health threat to bystanders. In other words, there is no evidence that secondhand vaping poses any health hazards.

Perhaps it would be helpful here for me to present my philosophy regarding the criterion that justifies government action to ban a personal behavior in order to protect the health of bystanders. The criterion I have always adhered to is that the burden of proof is on the government to demonstrate that the behavior in question endangers the health of others. There must be substantial evidence, in other words, that a health hazard exists. The mere possibility of a health hazard is not, in my opinion, sufficient to justify banning a widespread public behavior.

For example, when I have lobbied for laws and regulations to ban smoking in the workplace, my testimony has always been based on substantial evidence of the health hazards associated with secondhand smoke exposure. I never asked any city council or state legislative body to ban smoking in workplaces simply because of the "possibility" that secondhand smoke exposure might be harmful. I, and other anti-smoking advocates, did not demand government intervention until sufficient scientific evidence had accumulated to support the contention that secondhand smoke exposure in the workplace was a cause of health harm among exposed nonsmoking workers.

There are many exposures, which, from time to time, the media or the public associate with potential harm to the public. If government agencies banned these exposures every time there was mere speculation that the exposure might be harmful, it would prove to be an undue and overly burdensome level of intervention in the workplace.

For example, Action on Smoking and Health has argued that the breathe of smokers is itself toxic and has promoted the idea of banning smokers from the workplace simply because of speculation that exhaled toxins could threaten the health of nonsmokers. Would we not all agree that for the government to take such an intrusive action without actual evidence of harms to nonsmokers caused by exhaled chemicals from smoking employees would be inappropriate?

I have two other concerns about setting a precedent of the government banning behaviors in the absence of scientific evidence that those behaviors are causing health harm. First, might it undermine efforts to protect the public in situations where we really do have evidence of harm? In this case, I fear that basing a non-vaping regulation on no scientific evidence of harm could undermine efforts in other states - which do not yet have workplace smoking laws - to protect the public from the hazards of secondhand smoke in the workplace.

Second, banning electronic cigarette use in the workplace could place an undue burden on smokers who are trying to quit smoking using electronic cigarettes or ex-smokers who have successfully quit using e-cigarettes and who are trying to stay smoke-free.

Finally, I want to make it clear that I do not oppose the aspect of the proposed regulation regarding the sale of electronic cigarettes to minors. Certainly it is reasonable to make sure that electronic cigarettes cannot be easily purchased by minors. My comments relate solely to the portion of the proposed regulation that bans vaping in the workplace.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.